Edition 3.0 2020-01 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils électromédicaux – Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne IEC 60601-2-31:2020-01(en-fr) colour inside This is a preview of "IEC 60601-2-31:2020". Click here to purchase the full version from the ANSI store.
Transcript
IEC 60601-2-31
Edition 3.0 2020-01
INTERNATIONAL STANDARD NORME INTERNATIONALE
Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils électromédicaux – Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne
IEC
606
01-2
-31:
2020
-01(
en-fr
)
colourinside
This is a preview of "IEC 60601-2-31:2020". Click here to purchase the full version from the ANSI store.
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This is a preview of "IEC 60601-2-31:2020". Click here to purchase the full version from the ANSI store.
Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils électromédicaux – Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne
INTERNATIONAL ELECTROTECHNICAL COMMISSION
COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01
ISBN 978-2-8322-7671-6
Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.
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FOREWORD ........................................................................................................................... 4 INTRODUCTION ..................................................................................................................... 7 201.1 Scope, object and related standards ....................................................................... 8 201.2 Normative references ............................................................................................ 10 201.3 * Terms and definitions ......................................................................................... 10 201.4 General requirements ........................................................................................... 12 201.5 General requirements for testing ME EQUIPMENT .................................................... 13 201.6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................... 13 201.7 ME EQUIPMENT identification, marking and documents ........................................... 13 201.8 Protection against electrical HAZARDS from ME EQUIPMENT ..................................... 17 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ........... 23 201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 23 201.11 Protection against excessive temperatures and other HAZARDS ............................. 23 201.12 Accuracy of controls and instruments and protection against hazardous
outputs ................................................................................................................. 24 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 29 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................. 29 201.15 Construction of ME EQUIPMENT ............................................................................... 29 201.16 ME SYSTEMS .......................................................................................................... 29 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ........................... 29 202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests ............................... 29 Annexes ............................................................................................................................... 31 Annex I Identification of IMMUNITY pass/fail criteria ............................................................... 31 Annex AA (informative) Particular guidance and rationale .................................................... 32 Bibliography .......................................................................................................................... 52 Index of defined terms used in this particular standard .......................................................... 53 Figure 201.101 – Test waveform Vtest implemented by example RCL circuit using C = 120 µF, L = 25 µH, RL + R = 1 Ω .................................................................................... 18 Figure 201.102 – Example circuit of defibrillation test voltage generator for generating a decaying exponential waveform ......................................................................................... 19 Figure 201.103 – Test setup for a SINGLE CHAMBER external CARDIAC PACEMAKER .................. 20 Figure 201.104 – Test setup for a DUAL CHAMBER external CARDIAC PACEMAKER ..................... 20 Figure 201.105 – Test setup for a triple chamber external CARDIAC PACEMAKER, e.g. bi-ventricular external CARDIAC PACEMAKER ................................................................................ 21 Figure 201.106 – Timing sequence ....................................................................................... 21 Figure 201.107 – Measuring circuit for the PATIENT AUXILIARY CURRENT for ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE ................................................. 23 Figure 201.108 – Measuring circuit for the MAXIMUM TRACKING RATE ...................................... 26 Figure 201.109 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE ......... 27 Figure AA.1 – Simple model of a SINGLE CHAMBER EXTERNAL PACEMAKER during defibrillation .......................................................................................................................... 39
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Figure AA.2 – First proposal for a defib-protection test of SINGLE CHAMBER EXTERNAL PACEMAKER ............................................................................................................................ 41 Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according to conditions during open heart surgery ................................................................................ 42 Figure AA.4 – Defibrillation PULSE generated by the defibrillation test generator from Figure AA.3 .......................................................................................................................... 43 Figure AA.5 – Rise times of a defibrillation PULSE according to the circuit proposed in Figure AA.3 .......................................................................................................................... 47 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements ...................................... 12 Table 201.102 – DUAL CHAMBER connector terminal marking.................................................. 14 Table 201.103 – ME EQUIPMENT parameters ........................................................................... 25 Table 202.101 – Static discharge requirements ..................................................................... 30 Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory ........................................................... 33 Table AA.2 – PULSE energies calculated for C = 120 µF ± 5 % .............................................. 44 Table AA.3 – PULSE energies calculated for C = 122 µF ± 5 % .............................................. 45 Table AA.4 – PULSE energies calculated for C = 126,32 µF ± 5 % ......................................... 46
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Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-31 has been prepared by a Joint Working Group of IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee SC6: Active implants, of ISO technical committee 150: Implants for surgery.
This publication is published as a double logo standard.
This third edition cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
The requirement for testing for energy reduction has been removed; The test for exposure to external defibrillation has been completely revised;
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The exclusion for testing ESD immunity only with respect to air discharges has been removed;
Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;
Additional rationale for all changes.
The text of this International Standard is based on the following documents of IEC:
FDIS Report on voting
62D/1719/FDIS 62D/1732A/RVD
Full information on the voting for the approval of this International Standard can be found in the report on voting indicated in the above table. In ISO, the standard has been approved by 10 P members out of 10 having cast a vote.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type; – test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with this document;
– "should" means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website.
This is a preview of "IEC 60601-2-31:2020". Click here to purchase the full version from the ANSI store.
The committee has decided that the contents of this document will remain unchanged until the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its contents. Users should therefore print this document using a colour printer.
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